Bibliographic Citation

Abstract

Medical research involving human subjects must follow ethical standards as outlined in the Declaration of Helsinki of the World Medical Association. The 3 journals J Ped Surg, Eur J Pediatr Surg and Pediatr Surg Int all require authors' statements regarding ethical approval and the patient or guardian informed consent for studies involving human subjects. It has previously been reported that ethical approval and informed consent is not documented in a considerable proportion of publications in other journals. The aim of this study was to investigate whether ethical approval and informed consent was documented in a consecutive series of publications involving human subjects in the 3 paediatric surgical journals.

BACKGROUND: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board (REB) approval and informed consent. Despite this prohibition ...

Background: International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires ...